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| ID | Type | Description | Link |
|---|---|---|---|
| 8671-2075 | Other Grant/Funding Number | Mead Johnson and Company LLC |
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The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.
Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fortification at 20 ml/kg/day feeding volume | Active Comparator | Human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day. |
|
| Fortification at 100 ml/kg/day feeding volume | Active Comparator | human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human milk fortifiers | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| The days to reach full enteral feeding volume (140 ml/kg/day). | 4 - 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Outcomes | Necrotizing Enterocolitis | until 36 weeks PMA |
| Neonatal Outcomes | Chronic Lung Disease | until 36 weeks PMA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanket D Shah, MBBS | UTHSC, Memphis, TN | Principal Investigator |
| Ajay J Talati, MD | UTHSC, Memphis, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee, Health Science Center, The Regional Medical Center | Memphis | Tennessee | 38163 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27112041 | Derived | Shah SD, Dereddy N, Jones TL, Dhanireddy R, Talati AJ. Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:126-131.e1. doi: 10.1016/j.jpeds.2016.03.056. Epub 2016 Apr 23. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Neonatal Outcomes | Feeding intolerance | Until full feeding volume |
| Neonatal Outcomes | Parental nutrition days | Until full feeding volume |
| Neonatal Outcomes | Ventilator days | until 36 weeks PMA |
| Neonatal Outcomes | Protein and caloric intake | until 4 weeks of life |
| Neonatal Outcomes | Growth anthropometry | until 4 weeks of life |
| D000091642 | Urogenital Diseases |